Isturisa Tablet, Coated
NDC Package 55292-331-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Isturisa (osilodrostat) tablets is iSTURISA is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. This formulation utilizes a tablet, coated delivery system. Marketed by Recordati Rare Diseases, Inc., this product is identified by NDC 55292-331 and is authorized under FDA application NDA212801.

Identification & Billing

NDC Package Code
55292-331-20
Package Description
20 TABLET, COATED in 1 BLISTER PACK
Product Code
55292-331
11-Digit Billing Format
55292033120
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isturisa
Non-Proprietary Name
Osilodrostat
Substance Name
Osilodrostat Phosphate
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OSILODROSTAT PHOSPHATE 5 mg/1
Pharmacologic Class
Usage Information
ISTURISA is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Regulatory & Marketing

Labeler Name
Recordati Rare Diseases, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212801
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-31-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55292-331). Click a package code to view its specific billing and regulatory data.

55292-331-60
60 TABLET, COATED in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55292-331-20 identifies a specific commercial package of 20 tablet, coated in 1 blister pack of Isturisa, a human prescription drug labeled by Recordati Rare Diseases, Inc.. This tablet, coated is formulated for oral use and contains osilodrostat phosphate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Recordati Rare Diseases, Inc. on March 31, 2020. The current certification is valid through December 31, 2026.

How is this Recordati Rare Diseases, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55292033120. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55292-331-20
11-Digit CMS (5-4-2)
55292-0331-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.